Alpha Tau and Tolmar partner to commercialise Alpha DaRT in U.S.
Alpha Tau Medical and Tolmar International have signed a strategic collaboration granting Tolmar exclusive U.S. commercialisation rights for Alpha DaRT — the Israeli company's intratumoral alpha-radiation platform — in prostate cancer, with an option to extend into bladder cancer.
The deal delivers immediate capital to Alpha Tau: a $20 million equity investment at $11.99 per share, representing a 25% premium to the 30-day volume-weighted average price, plus a $15 million commitment from Tolmar toward a new U.S. manufacturing facility. The milestone schedule adds up to $96.5 million in development and regulatory payments for the first indication and a further $65 million in commercial milestones, bringing the potential deal value to $196.5 million across both tranches. Should Tolmar exercise its bladder cancer option, a further $10 million in upfront-equivalent payments and another $96.5 million in clinical and regulatory milestones become available.
How the technology works
Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) delivers alpha-particle radiation directly inside a solid tumour via recoiling radioisotopes seeded at the tumour site. The mechanism is designed to achieve highly localised cell kill while limiting exposure to surrounding healthy tissue — a profile that Alpha Tau says is particularly relevant in prostate cancer, where standard-of-care radical prostatectomy carries well-documented long-term complication rates including erectile dysfunction and urinary incontinence. Alpha Tau has already treated patients in Israel and holds an FDA Investigational Device Exemption (IDE) for a U.S. trial.
Under the commercial structure, Alpha Tau retains manufacturing and clinical development responsibility, supplying the device to Tolmar at 60% of Tolmar's net sales price. Tolmar takes full control of U.S. commercialisation — pricing, customer engagement and sales execution — for an expected term of 20 years from first commercial sale. Tolmar also holds rights of first negotiation on additional Alpha Tau urological-cancer products and certain geographic opportunities.
"Working alongside Tolmar, a top commercial leader with a keen understanding of this market, unlocks a vital channel with the potential to reach tens of thousands of patients per year in this first urological indication alone," said Uzi Sofer, chief executive of Alpha Tau.
Market context
The uro-oncology market is an increasingly contested space. Established radiation modalities — external-beam radiotherapy and brachytherapy — face competition from focal therapies such as high-intensity focused ultrasound (HIFU) and cryoablation, while next-generation radiopharmaceuticals, including Novartis's lutetium-177-based Pluvicto (approved for metastatic castration-resistant prostate cancer in 2022), have demonstrated that targeted radioactive approaches can achieve regulatory and commercial traction. Alpha DaRT's intratumoral delivery route positions it as complementary to — rather than directly competing with — systemic radiopharmaceuticals, though clinical data in U.S. populations remain pending.
Tolmar brings a specialist commercial infrastructure to the alliance, with 22 marketed products and five NDAs across urology and oncology. For Alpha Tau, whose pipeline also includes glioblastoma, pancreatic cancer and squamous cell carcinoma programmes, the Tolmar partnership offloads U.S. commercial build costs while preserving all rights outside prostate and bladder cancer in the U.S. and all global rights outside the U.S.
The next key milestone for both parties will be initiating the U.S. pivotal trial under the existing IDE and progressing toward a premarket approval (PMA) submission with the FDA. Given the device-based regulatory pathway — Alpha DaRT is a medical device under FDA jurisdiction rather than a drug — the PMA timeline and the clinical evidence package required will be closely watched by investors tracking the $96.5 million regulatory milestone payments.